ATTUNE 2544-01-006Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL IMPACTOR · Class 1
Quick summary
This DePuy ATTUNE femoral impactor has 2,544 adverse event reports, with no deaths and 3 injuries. Most reports describe the tool breaking, cracking or splitting, sometimes while it is used to impact the implant. One recall is closed, starting in November 2014, over impactors that broke into small pieces, which could remain in a patient if the break went unnoticed during surgery.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 2,539
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2,539 adverse event reports that list this exact device (DI 10603295130222), received between Jun 23, 2017 and Sep 29, 2026 — classified as 3 injuries, 2,536 malfunctions.
The most frequently reported specific device problem is “Break” (2,205 reports).
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Nov 10, 2014Terminated
ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
Z-0905-2015 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Break2,205
- Crack528
- Naturally Worn56
- No Apparent Adverse Event25
- Adverse Event Without Identified Device or Use Problem16
- Scratched Material16
- Component Missing12
- Contamination /Decontamination Problem11
Patient problems
- No Clinical Signs, Symptoms or Conditions1,433
- No Consequences Or Impact To Patient895
- Insufficient Information124
- No Information86
- No Code Available32
- Not Applicable18
- No Known Impact Or Consequence To Patient3
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 2,539 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931256 ↗MalfunctionSep 28, 2026Break; Crack
It was reported that the femoral and rotating platform (RP) tibia impactors were cracked and breaking.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913102 ↗MalfunctionSep 28, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912782 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903849 ↗MalfunctionSep 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885861 ↗MalfunctionSep 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885050 ↗MalfunctionSep 23, 2026Crack
It was reported that an Attune trial extractor broke while removing a trial insert. The single broken piece was recovered. It was also noted that the Attune femoral impact impactor had cracks in it.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872052 ↗MalfunctionSep 23, 2026Break
It was reported that femoral impactor broken during femoral implantation. All pieces retrieved, no further information at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868971 ↗MalfunctionSep 22, 2026Break
It was reported that the femoral impactor device was broken during impaction of trial femur.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852276 ↗MalfunctionSep 21, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845850 ↗MalfunctionSep 21, 2026Break
It was reported that the femoral impactor broke while cleaning. The event did not happen in surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841965 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794584 ↗MalfunctionAug 7, 2026Break
It was reported that the femoral impactor device fractured upon impact. It was reported that there was no procedural delay and no harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50180278 ↗MalfunctionJul 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25801823 ↗MalfunctionJul 10, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25784354 ↗MalfunctionJul 1, 2026Break
IT WAS REPORTED THAT THE IMPACTED PRODUCTS WERE FOUND FRACTURED DURING ASSEMBLY. THE EVENT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25682910 ↗MalfunctionJun 25, 2026Break
BROKEN FEMORAL IMPACTOR REPORTED. PATIENT STATUS/ OUTCOME / CONSEQUENCES. NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25628312 ↗MalfunctionJun 22, 2026Break
IT WAS REPORTED THAT FEM IMPACTORS BROKE. PIN DRIVERS ARE STRIPPED. PRESS FIT TIBIA DRILL DULL. 3-5 RING IS CRACKING. FEM DRILL IS DULL. BOX OSTEOTOME ARE BENDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578839 ↗MalfunctionJun 22, 2026Break
IT WAS REPORTED THAT FEM IMPACTORS BROKE. PIN DRIVERS ARE STRIPPED. PRESS FIT TIBIA DRILL DULL. 3-5 RING IS CRACKING. FEM DRILL IS DULL. BOX OSTEOTOME ARE BENDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578828 ↗MalfunctionJun 22, 2026Break
IT WAS REPORTED THAT FEM IMPACTORS BROKE. PIN DRIVERS ARE STRIPPED. PRESS FIT TIBIA DRILL DULL. 3-5 RING IS CRACKING. FEM DRILL IS DULL. BOX OSTEOTOME ARE BENDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578804 ↗MalfunctionJun 22, 2026Break
IT WAS REPORTED THAT FEM IMPACTORS BROKE. PIN DRIVERS ARE STRIPPED. PRESS FIT TIBIA DRILL DULL. 3-5 RING IS CRACKING. FEM DRILL IS DULL. BOX OSTEOTOME ARE BENDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578764 ↗MalfunctionJun 10, 2026Crack
IT WAS REPORTED THAT THE FEMORAL AND TIBIAL IMPACTORS BOTH CRACKED DURING SURGERY. THE IMPACTOR DID BREAK INTO SEVERAL PIECES. STAFF OPENED UP A BACKUP UNIVERSAL IMPACTOR. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25457926 ↗MalfunctionJun 9, 2026Break
IT WAS REPORTED THAT IMPACTOR BROKE DURING SECONDARY IMPACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25449084 ↗MalfunctionJun 5, 2026Break
IT WAS REPORTED THAT THE FEMORAL IMPACTOR WAS BROKE. THE DEVICE BROKE INTO TWO PIECES. YES THE FRAGMENTS WERE GENERATED AND RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410941 ↗MalfunctionJun 5, 2026Break
IT WAS REPORTED THAT THE IMPACTOR BROKE DURING FEMORAL IMPACTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410129 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
- SELF CENTERING 2055-13-000Depuy (Ireland) · IMPACTOR324 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.